Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
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ClinicalTrials.gov Identifier: NCT01229202 |
Recruitment Status : Unknown
Verified June 2011 by Nova Scotia Health Authority.
Recruitment status was: Recruiting
First Posted : October 27, 2010
Last Update Posted : July 1, 2011
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Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.
The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.
Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glaucoma | Drug: Bevacizumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery |
Study Start Date : | July 2008 |
Estimated Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: standard of care
standard of care for trabeculectomy surgery
|
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin |
Active Comparator: bevacizumab arm |
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin |
- post surgery IOP (Intra Ocular Pressure Measurement) [ Time Frame: one year post surgery ]
- bleb appearance [ Time Frame: one year post surgery ]
- number of bleb needlings [ Time Frame: one year post surgery ]
- number of glaucoma medications at 12 months postoperatively [ Time Frame: one year post surgery ]
- eye complications [ Time Frame: one year post surgery ]
- systemic complications [ Time Frame: one year post surgery ]
- need for another glaucoma surgery to control glaucoma [ Time Frame: one year post surgery ]
- postoperative visual acuity at 12 months [ Time Frame: 12 months post surgery ]

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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- any type of glaucoma, except neovascular or inflammatory
- patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery
Exclusion Criteria:
- younger than 30 years of age
- previous ocular surgeries excepting cataract surgeries
- patients who have had or present with intraocular inflammation
- neovascular glaucoma
- patients who are aphakic
- diabetic retinopathy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229202
Contact: Lesya Shuba, MD, PhD | 902 473-3410 | lshuba@dal.ca | |
Contact: Mimi Stanfield, BA | 901 473-3236 | stanfieldmj@dal.ca |
Canada, Nova Scotia | |
CDHA | Recruiting |
Halifax, Nova Scotia, Canada, B3H 2Y9 |
Principal Investigator: | Lesya Shuba, MD PhD | CDHA Halifax Nova Scotia Canada |
Responsible Party: | Lesya Shuba MD FRCSC PhD, Capital District Health Authority, Halifax, Nova Scotia,Canada |
ClinicalTrials.gov Identifier: | NCT01229202 |
Other Study ID Numbers: |
CD-2007-331 |
First Posted: | October 27, 2010 Key Record Dates |
Last Update Posted: | July 1, 2011 |
Last Verified: | June 2011 |
trabeculectomy glaucoma surgery bevacizumab Vascular Endothelial Growth Inhibitor glaucoma |
Glaucoma Ocular Hypertension Eye Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |